NCT00051584终止2 期
A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 60
- 试验地点
- 12
研究概览
简要总结
This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease
- •Patients must have > 20% Lewis-y antigen expression documented by immunohistochemistry
- •LVEF > 50% by echo or MUGA
- •Must be platinum resistant as defined by:
- •Progression while on initial platinum therapy or
- •Progression while on retreatment with initial platinum regimen or
- •Relapse < 6 months after initial therapy
- •Brief Overview of
排除标准
- •Patients who have had prior therapy with Gemzar®
- •Cumulative anthracycline exposure > 300 mg/m2
- •More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)
研究者
研究点 (12)
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